The ORA Electronic Reading Room displays copies of ORA domestic inspection and related records. We are making these records publicly available either (1) proactively at our discretion or (2) because they are "frequently requested" per the Electronic Freedom of Information Act Amendments of 1996. Some records may be redacted to remove non-public information (see 21 CFR Part 20). For publicly available ORA data sets, (such as lists of inspection classifications, 483 observations, etc.), please visit the data sets page. For other ORA documents, please visit the ORA home page and the FDA Warning Letter page. For foreign inspection and related records, please search the relevant center reading room page on the main FDA Electronic Reading Room.

In the event you are unable to read these documents or portions thereof, please contact ORA’s Division of Information Disclosure Policy [email protected]. If you are unable to find documents that you are looking for you may file a FOIA request for the records at https://www.fda.gov/regulatory-information/freedom-information/how-make-foia-request.

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Content for the ORA FOIA Electronic Reading Room is available on FDA's website for five years before being archived.

To find FOIA archived content for years prior to 2012, visit https://wayback.archive-it.org/7993/20170404012657/https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/default.htm.

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FOIA Record Type - Any - 483 483 Response Adverse Determination Letter Adverse Determination Letter Response Amended 483 Consent Decree Consent Decree Correspondence Consumer Complaint Record Establishment Inspection Report (EIR Exhibits and Attachments FDA Requested Recall Letter FMD-145 Letter Investigation Memo Memo Other Correspondence Recall Record Receipt of Payment Letter Response Resumption of Operations Authorization Letter Sample Record State Referral Letter >Untitled Letter Warning Letter Response Workplan

Company Name	Record Date	FEI Number	Record Type	State	Establishment Type	Publish Date	Excerpt
The Wellness Center Pharmacy, Inc., dba Designer Drugs	02/06/2019	3004578635	State Referral Letter	Tennessee	Producer of Non Sterile Drug Products	03/10/2020
Pacifico National, Inc. dba AmEx Pharmacy	05/31/2019	3012034698	483	Florida	Outsourcing Facility	07/22/2019
ADM Animal Nutrition	06/11/2019	1920783	Other Correspondence	Nebraska	Manufacturer	07/12/2019
Topway Enterprises	02/08/2019	3000204829	483	Texas	Manufacturer	08/19/2019
Compound Care Pharmacy 483 Issued 05/16/2019	05/16/2019	3006269306	483	Kentucky	Producer of Sterile and Non Sterile Drug Products	07/22/2019
Avexis	08/02/2019	3014617030	483	California	Control Testing Laboratory	08/08/2019
Puget Sound Drug Corporation dba Key Pharmacy and Compounding Center	06/13/2019	3006089725	483	Washington	Producer of Sterile and Non Sterile Drug Products	07/12/2019
California Specialty Pharmacy Inc.	05/17/2019	3015131323	483	California	Producer of Non Sterile Drug Products	07/12/2019
Pharmacy Plus, Inc. dba Vital Care Compounder	05/16/2019	3010241801	483	Mississippi	Producer of Sterile and Non Sterile Drug Products	07/12/2019
The Pet Apothecary LLC	08/07/2018	3005946041	483	Wisconsin	Producer of Non Sterile Drug Products	07/12/2019

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